Five-year follow up of a randomised controlled trial comparing subtotal with total abdominal hysterectomy

TY - JOUR

T1 - Five-year follow up of a randomised controlled trial comparing subtotal with total abdominal hysterectomy

AU - Andersen, L L

AU - Zobbe, V

AU - Ottesen, B

AU - Gluud, C

AU - Tabor, A

AU - Gimbel, H

AU - Danish Hysterectomy Trial Group

N1 - © 2014 Royal College of Obstetricians and Gynaecologists.

PY - 2015/5/1

Y1 - 2015/5/1

N2 - OBJECTIVES: To compare the rates of urinary incontinence (UI) and other complications of subtotal abdominal hysterectomy (SAH) with total abdominal hysterectomy (TAH) at 5 years after surgery.DESIGN: Randomised clinical trial with central, computer-generated randomisation.SETTING: Danish multi-centre trial performed in 11 departments of gynaecology.POPULATION: Women referred with benign uterine diseases scheduled for abdominal hysterectomy.METHODS: Women were randomised to either SAH (n = 161) or TAH (n = 158). Follow-up data were collected from participants using postal questionnaires sent out 5 years after surgery. Complications of hysterectomy were further examined by scrutinising registered discharge summaries following hospitalisation. Intention-to-treat and per-protocol analyses were conducted. Potential bias caused by missing data was handled using multiple imputation.MAIN OUTCOME MEASURES: The primary outcome was UI. Secondary outcomes included constipation, prolapse of the vaginal vault or cervical stump, satisfaction with sexual life, pelvic pain, postoperative complications and vaginal bleeding.RESULTS: The response rate was 234/319 (73.4%). A significantly higher proportion of respondents had urinary incontinence 5 years after SAH 34/113 (30.1%) than TAH 21/119 (17.6%) (RR 1.71, 95% confidence interval 1.06-2.75, P = 0.026). This difference reduced after multiple imputation to account for missing data (RR 1.37, 95% confidence interval 0.99-1.89, P = 0.052). Eleven of the 101 women (11%) in the SAH group still experienced vaginal bleeding. No other differences were found between the two types of abdominal hysterectomy.AUTHORS' CONCLUSIONS: A smaller proportion of women suffered from UI after TAH than after SAH 5 years postoperatively. Around one in ten women continued to experience vaginal bleeding 5 years after SAH.

AB - OBJECTIVES: To compare the rates of urinary incontinence (UI) and other complications of subtotal abdominal hysterectomy (SAH) with total abdominal hysterectomy (TAH) at 5 years after surgery.DESIGN: Randomised clinical trial with central, computer-generated randomisation.SETTING: Danish multi-centre trial performed in 11 departments of gynaecology.POPULATION: Women referred with benign uterine diseases scheduled for abdominal hysterectomy.METHODS: Women were randomised to either SAH (n = 161) or TAH (n = 158). Follow-up data were collected from participants using postal questionnaires sent out 5 years after surgery. Complications of hysterectomy were further examined by scrutinising registered discharge summaries following hospitalisation. Intention-to-treat and per-protocol analyses were conducted. Potential bias caused by missing data was handled using multiple imputation.MAIN OUTCOME MEASURES: The primary outcome was UI. Secondary outcomes included constipation, prolapse of the vaginal vault or cervical stump, satisfaction with sexual life, pelvic pain, postoperative complications and vaginal bleeding.RESULTS: The response rate was 234/319 (73.4%). A significantly higher proportion of respondents had urinary incontinence 5 years after SAH 34/113 (30.1%) than TAH 21/119 (17.6%) (RR 1.71, 95% confidence interval 1.06-2.75, P = 0.026). This difference reduced after multiple imputation to account for missing data (RR 1.37, 95% confidence interval 0.99-1.89, P = 0.052). Eleven of the 101 women (11%) in the SAH group still experienced vaginal bleeding. No other differences were found between the two types of abdominal hysterectomy.AUTHORS' CONCLUSIONS: A smaller proportion of women suffered from UI after TAH than after SAH 5 years postoperatively. Around one in ten women continued to experience vaginal bleeding 5 years after SAH.

KW - Adult

KW - Female

KW - Follow-Up Studies

KW - Humans

KW - Hysterectomy

KW - Intention to Treat Analysis

KW - Logistic Models

KW - Middle Aged

KW - Postoperative Complications

KW - Surveys and Questionnaires

KW - Treatment Outcome

KW - Urinary Incontinence

KW - Uterine Diseases

U2 - 10.1111/1471-0528.12914

DO - 10.1111/1471-0528.12914

M3 - Journal article

C2 - 24917531

SN - 0140-7686

VL - 122

SP - 851

EP - 857

JO - The Journal of obstetrics and gynaecology of the British Commonwealth

JF - The Journal of obstetrics and gynaecology of the British Commonwealth

IS - 6

ER -